In Second Case of Flawed Drug Research, FDA Response Was Slow and Secretive
The FDA now is overtly subservient to the industry it is tasked with regulating. Rob Garver and Charles Seife report in ProPublica:
This week, we reported that the Food and Drug Administration left medicines on the market for years after discovering they were approved based on fraudulent studies by Cetero Research, which did testing for drug companies worldwide.
Turns out that wasn’t an anomaly: The agency’s slow, secretive response in the Cetero case mirrors how it handled an earlier instance of scientific misconduct at another contract research organization, MDS Pharma Services.
The FDA found that data produced from 2000 through 2004 at two MDS facilities in Quebec, Canada, were questionable.
As it would do with Cetero, the FDA announced it was requiring drug manufacturers to redo many of the MDS studies conducted during the five-year problem period. And, just as in the Cetero case, the agency declined to make public a list of the 217 generic drugs, both on the shelves and awaiting approval, that it said could be affected by MDS’ potentially faulty research.
Instead, the FDA assured the public that all affected drugs were safe and effective, even as it was requiring re-testing of many of those medicines.
As with Cetero, most of the tests the FDA was concerned about were “bioequivalence” tests, designed to show whether a generic drug is equivalent to the original name-brand drug. In response to detailed questions, the FDA said, “We did not receive evidence suggesting that the original bioequivalence studies were flawed, as most if not all of the confirmatory audit, reassay, or repeat studies supported the original conclusions of bioequivalence.” At the time the FDA called its action “a precautionary measure to ensure that data submitted to the Agency and used in making approval decisions is of the highest quality.”
A spokesperson for the parent company of MDS Pharma Services, which has renamed itself Nordion, sent the following statement to ProPublica: “Matters relating to the labs formerly operated by MDS Pharma currently are the subject of ongoing litigation. Accordingly, we decline comment at this time.”
The first hint of trouble at MDS Pharma came in July 2003, when . . .
As I blogged earlier today, in Scotland people get sent to prison for falsifying data. In the US, the government seems to think it’s okay.